MAUDE Adverse Event Report: COOK IRELAND LTD. ECHOTIP PROCORE HD EBUS FOR PENTAX SCOPES; BIOPSY NEEDLE

Model Number	G34279
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported by the pulmonologist performing the biopsy and by the bronch lab staff that they have had several incidents with the echotip procore hd ebus for pentax scopes.The most recent complaint reported is that during procedure, the pulmonologist was unable to deploy the needle for biopsy.Prior to procedure, the deployment was checked to ensure that it was functioning properly, however, it malfunctioned during procedure.This is the majority of the complaints received.Additionally, there are multiple complaints of the sheath not deploying straight, it slides off and bends the needle ultimately leading to the inability to obtain biopsy and having to use additional needles.

• Brand Name: ECHOTIP PROCORE HD EBUS FOR PENTAX SCOPES
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD.; limerick ; EI
• MDR Report Key: 8420702
• Report Number: MW5084900
• Device Sequence Number: 2326952
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)220121(10)
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2022
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1577896
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR